Floridian Parents Continue to Find Toxic Baby Foods on Shelves, FDA Still on Standby to Regulate Heavy Metals

On the heels of a 2019 study that uncovered high amounts of heavy metals in infant nutritional products, the Subcommittee for Economic and Consumer Policy conducted its own investigation to assess the actual extent of the issue. 

The Subcommittee’s report published in February 2021 surfaced a host of lacking industry standards that allowed baby food products to be contaminated with neurotoxic cadmium, mercury, lead, and inorganic arsenic. While the FDA initiated a multi-step plan seeking to regulate these dangerous contaminants, its strategy has yet to produce substantive developments that would protect vulnerable consumers, falling behind on its stated schedule. 

How heavy metals end up in baby food products

The Subcommittee's investigation focused on seven major baby food manufacturers whose products are readily available on US store shelves. Although Gerber, Beech-Nut, Hain Celestial, and Nurture provided the requested internal data, Walmart, Sprout Food, and Campbell declined to offer any such information.

Drawing on the limited information at their disposal, the Subcommittee identified inadequate safety standards and practices that contributed to widespread contamination. Manufacturers rarely (if ever) tested their products for mercury, would only evaluate ingredients and skip final product analysis, some used harmful additives, and some even knowingly commercialized contaminated products. Compared to safety limits that govern other FDA-regulated products, baby foods contained 5 times more mercury, 69 times more cadmium, 91 times more inorganic arsenic, and 177 times more lead.

Infants and toddlers are especially susceptible to dietary exposure to toxic metals due to their higher intestinal uptake of nutrients and underdeveloped filtering systems. As they gradually build up in the body, these elements act as neurotoxins and can progressively impair brain and nervous system functions, leading to lower IQs and atypical behavior patterns. Recent systematic reviews and meta-analyses have found that early exposure to cadmium, mercury, lead, and inorganic arsenic is linked to the development of autism spectrum disorders (ASD).     

FDA's slow and ineffective strategy

Taking note of the Subcommittee's findings, the FDA initiated its Closer to Zero plan in April 2021, seeking to establish suitable heavy metal safety limits for infant nutritional products. However, the strategy has been criticized for its structural redundancies and laxed timeline, which would propose actionable levels by 2024, if not longer.

The plan's primary and secondary steps of elaborating and proposing safety limits are considered needlessly time-consuming since a vast volume of data from reputable sources already covers the topic. By circumventing these repetitive processes and focusing on the final two steps that target implementation, the plan could reach its goals even earlier than the 2024 deadline.  

Before the Closer to Zero plan, the FDA only provided guidance and proposed actionable levels (though not enforced) for inorganic arsenic in infant cereals at a contested 100 ppb (parts per billion) limit, addressing only one hazard in a limited range of products. In September 2021, the subcommittee published an updated report that included data from the formerly uncooperative manufacturers, indicating even more prevalent contamination than initially anticipated. 

The lack of effective institutional regulations means that baby food manufacturers are allowed to follow their own internal safety standards, which don't always stand up to scrutiny. Unsuspecting parents could be unwittingly feeding their offspring heavy metal-contaminated food since the general assumption is that commercialized products are also safe. This is especially concerning for states like Florida, where ASD diagnoses are the highest among all US states.  

Lingering legislation and attorneys general backlash 

Hoping to conclude the contamination crisis quicker, Rep. Raja Krishnamoorthi (D-IL) submitted the Baby Food Safety Act in March 2021. The bill sought to mandate transparent biannual reporting from manufacturers on final-product testing, expand FDA's regulatory attributes and involvement, and require the CDC to engage in a public awareness campaign regarding hazardous neurotoxic metals. Most importantly, it proposed setting interim safety levels that would be subject to further reductions over time:

• Mercury: 2 ppb
• Cadmium and Lead: 5 – 10 ppb
• Inorganic Arsenic: 5 – 10 ppb   

However, since the committee it was referred to didn't call for a hearing or vote on the bill, the Baby Food Safety Act's progress was effectively halted. In October 2021, a coalition of 23 Attorneys General petitioned the FDA to accelerate its plans timeline and adopt the bill's proposed interim levels by April 2022.     

The FDA rejected the petition in May 2022, citing issues with the proposed methodology, which was subsequently contested by the petitioners, followed by a letter that reiterated the need for "timely action" to protect vulnerable consumers who risk being exposed to toxic metals for several more years unless expeditious action is taken.

The FDA's reticent actions and lackluster strategy still allow manufacturers to sell contaminated products to this day. In early January 2023, Bloomberg Law found that 32 of the 33 baby food products it purchased and tested through accredited third-party laboratories contained at least two of three neurotoxic metals. Notably, several of the tested items came from companies that were previously part of the subcommittee's investigation.

Nearly two years after its launch, the FDA finally proposed action levels for lead in baby food products in January 2023, deeming concentrations between 10 ppb and 20 ppb acceptable. However, these limits were supposed to be proposed in April 2022 per the Closer to Zero plans' timeline.

Although Florida AG Ashley Moody wasn't among the coalition's signatories, former state governor and current Republican senator Rick Scott expressed his concerns in February 2023 letter addressed to FDA's commissioner. Sen. Scott noted that the recent guidelines don't reduce lead levels in a significant manner to ensure children's safety and fail to address other hazardous metal contaminants.

Since manufacturers have repeatedly demonstrated that their measures don't prevent toxic metal contamination, the FDA should leverage its authority and urgently establish more stringent regulations that ensure baby food products' safety and keep liable companies accountable. Even though the Baby Food Safety Act effectively died in committee, Rep. Krishnamoorthi has indicated that he intends to reintroduce the bill in the new Congress. Hopefully, the FDA will heed the bill's recommendations as it moves towards accomplishing its "Closer to Zero" goal. 

In the meantime, by virtue of the Toxic Baby Food Replacement Campaign, those who would like to access free of charge baby food packages from ethical companies, that test for heavy metals, can request them here. 

About the Author

Jonathan Sharp serves as CFO at the Birmingham, Alabama-based Environmental Litigation Group PC, a law firm that specializes in toxic exposure litigation and helps parents whose children develop illnesses after consuming adulterated and unsafe products.